1.0E+6 MSC/kg, IV drop and repeat to apply in Day 90 if the effect of MSC is better. At the same time, patient continues to apply the former oral hypoglycemic drugs, such as Dimethylbiguanide, Glurenorm and Acarbose, et al. and regulates the dosage for 1 year.

Biological: MSC

1.0E+6 MSC/kg, IV drop in Day 0 and repeat to apply in Day 90 if the effect of MSC is better.

Experimental: MSC and insulins

1.0E+6 MSC/kg, IV drop and repeat to apply in Day 90 if the effect of MSC is better. At the same time, patient continues to apply the former insulins and regulates the dosage for 1 year.

Biological: MSC

1.0E+6 MSC/kg, IV drop in Day 0 and repeat to apply in Day 90 if the effect of MSC is better.

Experimental: MSC and the combination of drugs and insulins

1.0E+6 MSC/kg, IV drop and repeat to apply in Day 90 if the effect of MSC is better. At the same time, patient continues to apply the former combination of the oral hypoglycemic drugs and insulins and regulates the dosage for 1 year.

Biological: MSC

1.0E+6 MSC/kg, IV drop in Day 0 and repeat to apply in Day 90 if the effect of MSC is better.

1st transplantation: after finishing all required examines according to protocol in Day 0, umbilical cord/placenta-derived MSCs are transplanted intravenously.

2nd transplantation: after finishing all required examines in Day 90, umbilical cord/placenta-derived-MSCs are transplanted intravenously if the effects of MSC are better than that before.

At the same time, patients continue taking the oral hypoglycemic drugs, insulins or the combination of the oral hypoglycemic drugs and insulins which the patients have taken for controlling the higher blood sugar from Day 0 for 1 year. But the dose of the oral hypoglycemic drugs and insulins should be regulated according to the level of blood sugar.

2. Detailed Description:

To evaluate the feasibility and safety of transplantation treatment using umbilical cord/placenta-derived mesenchymal stem cells in patients with type 2 diabetes mellitus undergoing the oral hypoglycemic drugs, insulins or the combination of the oral hypoglycemic drugs and insulins.

To assess efficacy of transplantation treatment using umbilical cord/placenta-derived mesenchymal stem cells in patients with type 2 diabetes mellitus undergoing the oral hypoglycemic drugs, insulins or the combination of the oral hypoglycemic drugs and insulins.

This study will last 2 to 3 years. Participants will be randomly assigned to receive either MSC transplant and the oral hypoglycemic drugs or MSC transplant and insulins or MSC transplant and the combination of the oral hypoglycemic drugs and insulins (experimental group) or the oral hypoglycemic drugs or insulins or the combination of the oral hypoglycemic drugs and insulins (control group). Patients will undergo MSC transplant at the start of the study on Day 0 and take the oral hypoglycemic drugs, insulins or the combination of the oral hypoglycemic drugs and insulins for 1 year. As control, some patients take the oral hypoglycemic drugs, insulins or the combination of the oral hypoglycemic drugs and insulins for 1 year. At the same time, the dose of the oral hypoglycemic drugs and insulins should be regulated according to the level of blood sugar. After 3 months, patients will receive the second MSC transplantation. After six and twelve months from the first transplantation, patients will be evaluated.

Eligibility

Ages Eligible for Study:

18 Years to 80 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Free will taking part in the study and ability to provide written informed consent

Patient has enrolled another clinical trial study within last 4 weeks.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01413035